Company Summary: Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro’s lead program is Alpha-1 Antitrypsin Deficiency (AATD). Korro is based in Cambridge, Massachusetts.

We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what’s possible in genetic medicine and work to make a lasting impact on human health.

POSITION SUMMARY

Korro Bio, Inc. is seeking an experienced Regulatory Affairs professional to join the Regulatory department and assist with and lead many of the Regulatory activities for Korro programs.

The Associate Director/Director of Regulatory Affairs, reporting to the VP of Regulatory Affairs, is a highly visible role responsible for ensuring that all clinical and nonclinical regulatory requirements and goals are met, from pathway planning to submissions, in accordance with industry standards. The right candidate will work closely with the VP of Regulatory Affairs, other members of the Regulatory team, and project team members.

Primary Responsibilites:

Provide Regulatory Strategy and also Operational guidance for programs and to project teams.
Manage regulatory aspects of programs including oversight and preparation of INDs, Briefing Books, Amendments, Annual Reports, Orphan Drug Designations, and eventual NDA/Marketing Application(s).
Act as the Regulatory Lead for assigned programs and projects and submissions to Global Health Authorities (FDA, EMA, etc.).
Facilitate the development of documentation for submission to regulatory authorities.
Collaborate with the Regulatory Operations/Publishing vendor when preparing submissions for submission via email, electronic Submission Gateway (ESG), and CTIS in Europe.
Lead project teams through meeting preparations for official meetings with Health Authorities (INTERACT, pre-IND, pre-CTA, End-of-Phase meetings, etc.)
Participate in and as needed lead interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, review, and approval of INDs, CTAs, NDAs/MAAs, amendments, and other submissions.
Develop and maintain relationships with regulatory authorities, internal departments, consultants, and other partners.
Articulate complex Regulatory issues to project teams and stakeholders to support development of Korro therapies.
Accountable for oversight of specific CROs and other vendors including vendor management.
Knowledgeable of the Regulations, Guidance, Laws, and ICH Guidelines.
Responsible for ensuring that Regulatory documents are prepared to industry and Health Authority standards.
Write and approve SOPs pertaining to Regulatory activities and documents.
Interact with other internal groups and lead project teams.
Make sound judgements taking into consideration patient safety, business risk, and compliance.
Manage and mentor any direct reports, as necessary.

Basic Qualifications:

Bachelor’s Degree, at minimum.
8-10+ years of experience working in the pharmaceutical/ biopharmaceutical industry.
Experience with CDER and/or CBER required, and experience with global Health Authorities preferred.
Excellent communication and writing skills.
Hands-on, roll-up-your-sleeves approach.
Understanding of eCTD requirements, submission requirements, ESG requirements.
Experience with preparation of meeting requests and submissions, including the generation of a variety of content for submissions (eg, INTERACT, pre-IND, IND, Annual Reports, BLA/NDA, MAA).

Preferred Qualifications:

Advanced Degree (MA/MS/MBA/PhD/PharmD) preferred.
Gene/Cell Therapy (AAV, Gene Editing, Anti-sense oligos) experience or expertise helpful.
Experience in a start-up or small company environment a plus!

Benefits: Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.

Associate Director/Director

Regulatory Affairs

Korro Bio

Primary Responsibilites:

Basic Qualifications:

Preferred Qualifications:

6 month growth

1 year growth

2 year growth

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